Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 23, 2021
Date Accepted: Mar 28, 2022
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Development and effectiveness of a mHealth intervention in improving Health Literacy and self-management of the multi-pathological patient with heart failure: A randomized controlled trial protocol.
ABSTRACT
Background:
Multi-morbidity patients with complex health needs are responsible for most avoidable hospital admissions. The increasing expansion of mHealth interventions in patient communication, the reduction of health inequalities, improved access to healthcare resources, adherence to treatment, and self-care of chronic diseases, all point to an optimistic outlook. However, few mobile applications demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, nor are they designed by and for users with different levels of health literacy.
Objective:
To evaluate the efficacy of a mHealth intervention relative to routine clinical practice in improving health literacy and self-management in a multi-pathological patient with heart failure and complex health needs. Methods and analysis: Randomized, multicenter, blinded clinical trial for evaluation with two groups: a control group (standard clinical practice) and an intervention group (standard clinical practice and ad hoc designed mHealth intervention). Results and practical implications: The mHealth will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management, and will be validated in content. The trial will demonstrate whether the mHealth intervention improves health literacy and self-management in patients with heart failure and complex health needs, improves therapeutic adherence, and reduces hospital admissions. Ethics and dissemination: This study has been approved by the Cadiz Research Ethics Committee. The aim of the study and the anonymity of participants, as well as the voluntary character of participation, will be explained before the participants start, and their informed consent will be requested. The participants will also be informed that the data obtained would be used for research purposes only. Trial Registration: ClinicalTrials.gov identifier: NCT04725526; https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT04725526&cntry=&state=&city=&dist=
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